Placental MSC products for scleroderma are not FDA-approved; treatment remains investigational. HSCT for severe systemic sclerosis is recognised as an investigational procedure in the United States and is performed at specialist centres but has no formal FDA approval as a disease-modifying therapy.
Systemic sclerosis (scleroderma) is an autoimmune disease characterised by pathologic fibrosis of skin and internal organs (lungs, heart, kidneys), driven by activated fibroblasts that overproduce collagen and other extracellular matrix proteins. The underlying immunological dysfunction involves autoreactive T cells, B cells producing pathogenic antibodies (anti-topoisomerase, anti-centromere), and dysregulated cytokine signalling (TGF-β, IL-6). Placental MSCs are being explored as an anti-inflammatory and immunomodulatory intervention, delivering cytokines and cell-surface molecules that suppress autoreactive immune cells and potentially reprogram fibroblast behaviour. Unlike conventional disease-modifying antirheumatic drugs (DMARDs), cell therapy aims to reset immune tolerance rather than merely suppress inflammation. Note: autologous haematopoietic stem-cell transplantation (HSCT) is an established, though intensive, option for severe early-stage systemic sclerosis in selected candidates, with demonstrated benefit in some clinical series.
Am I a candidate? → · Scleroderma (Systemic Sclerosis): full overview → · Scleroderma (Systemic Sclerosis) cost → · Cost →
Medically reviewed by StemCellAtlas’s editorial team with Dr Polina Krasenova (Haematologist · Clinical Haematology & Integrative Oncology · 15+ yrs cell therapy) of partner clinic Stem Plus (Sofia), against ISSCR, FDA & EMA guidance. Educational information, not medical advice; figures indicative.
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